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Recruiting NCT06781333

Human Mesenchymal Stem Cells (hMSC) in Behavioral Problems Due to Alzheimer's Disease.

Phase II Interventional Alzheimer Disease Agitation in Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: hMSC.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Agitation in Dementia. Basic parameters: 55 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pilot Study to Assess the Effect of Adding 1 Infusion of Human Mesenchymal Stem Cells (hMSC) to the Treatment of Patients Suffering Agitation/Aggression or Other Behavioral Abnormalities From Alzheimer's Disease.

Overview

The purpose of this research study is to test if adding one infusion of mesenchymal stem cells to the current treatment with antipsychotic medication may help control behavioral problems in people with a diagnosis of moderate to severe Alzheimer's disease.

Interventions

  • Biological hMSC
    Participants will come in person to receive one intravenous infusion of approximately 25 million cells up to 20 minutes.

Primary outcome measures

  • Neuropsychiatric Inventory [Time frame: Up to 12 weeks.]
Secondary outcome measures (2)
  • Change in antipsychotic medications dosage [Time frame: Baseline to 12 weeks]
  • Change in number of antipsychotic medications [Time frame: Baseline to 12 weeks]

Eligibility criteria

Inclusion criteria

  • Adults 55-90 years at the time of signing consent
  • A diagnosis of probable Alzheimer disease (AD), defined by the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • Previous computed tomography or magnetic resonance imaging scan of the brain with findings consistent with a diagnosis of Alzheimer disease
  • A diagnosis of behavioral symptoms that include any of the following: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and nighttime behavior disorders and appetite and eating disorders
  • Onset of behavioral symptoms at least 4 weeks prior to screening.
  • Treatment with antipsychotic medication for at least 4 weeks prior to the hMSC infusion.
  • Patients unable to consent should have a Legally Authorized Representative or Proxy to provide consent on their behalf.
  • Have a family member or friend (study partner) who has frequent and sufficient contact with the patient and able to answer questions about the participant's behavior.

Exclusion criteria

  • Dementia other than AD
  • Patient with severe depression. Patient with controlled depression is allowed to participate.
  • Recent history of substance abuse
  • History of bleeding disorders, HIV, Hepatitis C Virus or Hepatitis B Virus
  • Recent history (within 3 years) of malignancies, except for treated basal cell, squamous carcinoma or melanoma in situ, prostate in situ, cervical carcinoma in situ.
  • Uncontrolled medical conditions (hypertension, diabetes, unstable angina or Myocardial Infarction within 1 year prior to screening)
  • History of bleeding disorder
  • Currently receiving (or received within four weeks of screening) experimental agents for the treatment of Alzheimer's Disease or enrolled in clinical trials in the prior 3 months.
  • Be a transplant recipient or in any other active medical condition than in the opinion of the investigator may compromise the safety or compliance of the patient or preclude successful completion of the study
  • Be premenopausal

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Miami Department of Neurology — Miami

Identifiers

NCT: NCT06781333 · 20240984

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗